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Original Articles Open Access
Bendamustine hydrochloride is an active nitrogen mustard fragment and a residue of butanoic acid used for the treatment of chronic lymphocytic leukemia. Three simple, rapid and sensitive spectrophotometric methods are developed for the determination of Bendamustine hydrochloride in pharmaceutical dosage forms. The absorption maxima was found to be at 232.41 nm in phosphate buffer (pH 6.8) (Method A) and shows linearity over the concentration range of 0.1-50 μg ml-1 with regression equation 0.064x + 0.038 (r2 = 0.998). For Method B boric buffer (pH 9.0) was chosen in which the absorption maxima was observed at 229.25 nm and linearity was followed over the concentration range 0.5-50 μg ml-1 with regression equation is found to be 0.062x + 0.022 (r2 = 0.999). In Method C difference spectroscopy technique was used in which the maxima (343.32 nm) was chosen for the spectral analysis and linearity was followed over the concentration range 5-40 μg ml-1 with regression equation 0.006x + 0.001 (r2 = 0.998).The proposed methods can be successfully applied for the determination of Bendamustine hydrochloride in pharmaceutical formulations and validated according to ICH guidelines.
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Author(s): M Mathrusri Annapurna S Pavani S Anusha Harika Mahanti and B Venkatesh
Bendamustine hydrochloride, Difference spectroscopy, Validation, ICH, analytical